The FDA staff Tuesday said there is potential in Gilead Sciences' ($GILD) Truvada as a prophylactic to HIV infection among high-risk populations--say, those whose spouses are infected. So tomorrow it will be up to an advisory panel to say whether that potential is undercut too seriously by chance patients won't take it or that drug resistance is too likely.
The numbers in favor of Truvada are compelling. Truvada costs $14,000 a year, Bloomberg points out. But pit that against the 48,000 new cases of HIV that occur annually in the U.S., and those patients must then go on expensive regimens to treat the condition. There are 415,000 people in the U.S. alone considered by the CDC to be at high risk of contracting HIV, which can lead to AIDS. Worldwide, there are 34 million people who contracted HIV in 2009. In the U.S. there are currently 1.2 million people with the HIV infection, the Chicago Tribune reports.
Groups that work with HIV patients see the downside, however. There is always the problem of getting people to take the drug as required, difficult enough when people have a condition, more difficult perhaps when they don't. There is also the probability that people taking the drug would become resistant to its impact, which becomes a real problem if they do become infected, an issue the FDA staff noted. Then, some groups think that if people at high risk have a pill they think is going to be a shield against the disease, they will become cavalier about their sexual habits and not use condoms, and the U.S. will actually see HIV infections rise.
If approved, Howard Jaffe, chairman of the Gilead Foundation, told Bloomberg that the company would work with health agencies on demonstration projects to educate users and potential users.
Interestingly, UBS analyst Matthew Rodin says that for investors, the bigger news will be on Friday, when an advisory panel takes up Gilead's Quad HIV pill for controlling the HIV virus in those already infected, the Chicago Tribune reports. He says the upside potential of a Truvada approval is dampened by the fact that it is already being prescribed as an off-label prophylactic to some at risk. Rodin tells investors it is Quad that will determine whether Gilead maintains its dominance in HIV drugs.
In March, Gilead unveiled important details from a pivotal study for its Quad pill for HIV, showing the industry that the four-drug combo was as effective as its approved Atripla med without bringing on some of that treatment's side effects. And Atripla brought in the bulk of Gilead's $8.1 billion in revenue last year,
It is a big week for Gilead.
Truvada up for FDA debate as HIV preventive
AIDS advocates spar over preventive Truvada use
Gilead spotlights key details from pivotal Quad study